Detection of small, nonpalpable breast lesions has been greatly facilitated in recent years by the use of x-ray, mammography and/or sonography procedures. However, identification of a suspicious lesion does not establish its exact location within the breast. Heretofore, needle location of suspicious lesions using radiology has been a common approach. Some special variations have also been employed including a modified needle/hook wire technique.
Surgical excision has, in the past, resulted in several interrelated difficulties that contribute to inefficiency and inaccuracy. These difficulties include the fact that location of the lesion within the specimen is complicated by movement of the specimen on the x-ray film during transportation to pathology and during the pathological analysis. Further, this technique requires an extended period of anesthesia for the patient and is subject to inaccuracies and inconsistencies in the interpretation and communication to the surgeon of the pathologist's findings.
The present invention is the method of using an apparatus to secure the specimen during the transportation and pathological analysis in relation to a precise location defined by radio-opaque coordinates superimposed on the x-ray. In addition, the inclusion of a fixed orientation and radio-opaque coordinates for the excised specimen on the x-ray is extremely beneficial to the pathologist in localization of the suspicious lesion within the specimen to avoid a misdiagnosis.
The difficulties addressed by the present invention have also been recognized by the prior art as disclosed by a pre-examination search. The most relevant reference recognizing these concerns, and disclosed by the search, is Gabrielle et al., U.S. Pat. No. 4,691,333, which discloses a breast compression plate apparatus in combination with a mammographic film cartridge and attaching means therebetween which compression plate has a plurality of perforations disposed in a matrix for needle localization of breast lesions. However, this disclosure suffers from the difficulty that it can only be utilized in a single plane at one time, although separate use in two perpendicular planes is illustrated. Movement of the breast is restricted during the localization procedure in a given plane, but is not achievable when the disclosed apparatus is repositioned to a perpendicular plane. Contrariwise, the present invention contemplates three dimensional localization because of the use of a matrix of lines on a three dimensional diagrammatic representation of each breast rather than localization using a compression plate or similar physical apparatus that must be moved for two dimensional use, and must be removed during the surgical procedure.
Other references disclose the use of radio-opaque indicia in combination with x-rays. Cherry, U.S. Pat. No. 3,547,121, describes a radio-opaque grid for use with x-ray positioning of a needle for a fetal transfusion. The grid is attached to the pregnant women's abdomen and is used to identify in combination with x-ray the location of the fetus in the peritoneal cavity so that placement of the needle for injection of the fetus can be performed accurately. In this instance, the grid is left in place on the patient during the procedure to coordinate with the x-ray result after the same is developed.
A further and similar reference, is Vitalini, U.S. Pat. No. 4,181,859, which discloses a grid image printed in radio-opaque ink and adhesively attached to x-ray film to facilitate measurement on the exposed x-ray. It is adapted for use with flexible radiographic films that are commonly used in dentistry, and achieves a two-dimensional result even though the x-ray film undergoes the substantial deformations that are usual in dental radiography.
A further reference of lesser relevance is Bliss, U.S. Pat. No. 2,399,424, which discloses scales or indicia on the edge of an x-ray film to measure foot length and width and shoe size in connection with the fitting of shoes.
As more fully described hereinafter, the apparatus used in present invention also includes an absorbent square to which the specimen naturally adheres, a compression sheet placed over the specimen to obtain compression radiography, a target for positioning the specimen in the x-ray machine, and a sealable enclosure for transporting the specimen. The pre-examination search also revealed two references of very modest relevance to these latter aspects of the invention. The first of these references is Ammerman, U.S. Pat. No. 4,723,974, which teaches a transporting container for an amputated extremity. The reference discloses a multi-wall, flexible container intended to provide a cooling compartment to achieve a decreased temperature environment for the amputated extremity disposed within the inner compartment. The other reference is Winchell, U.S. Pat. No. 4,474,016 which teaches a sterile cooling system for organs during transplant surgery. The latter reference also discloses techniques for temperature reduction using a multi-layer structure.